Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

Novartis

Status and phase: Completed; Phase 3

Conditions: Male Osteoporosis

Treatments: Drug: Placebo; Drug: Zoledronic acid 5 mg iv

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439647

CZOL446M2309

Details and patient eligibility

About

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

Enrollment: 1,199 patients

Sex: Male

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae

Exclusion criteria

• Low Vitamin D
• Renal insufficiency
• Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,
• Previous treatment with testosterone, anabolic steroids or growth hormone
• Chronic use of systemic corticosteroids (oral or i.v.) within the last year
• History of any cancer or metastases within the last 5 years
• History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis
• Bilateral hip replacements

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,199 participants in 2 patient groups, including a placebo group

Zoledronic Acid

Experimental group

Description:

5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Treatment:

Drug: Zoledronic acid 5 mg iv

Placebo

Placebo Comparator group

Description:

100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Treatment:

Drug: Placebo